AstraZeneca: Diabetes Drug Receives Marketing Authorization In Europe
- Posted on 08 October 2009
AstraZeneca and Bristol-Myers Squibb Company have announced that the European Commission has granted marketing authorisation for Onglyza (saxagliptin) in the 27 countries of the European Union.
The drug is indicated as a once-daily 5 mg oral tablet dose in adult patients with type two diabetes mellitus to improve glycaemic control.
The marketing authorisation is based on data that has been submitted from a clinical development programme that included six core Phase III registrational trials and a Phase IIIB study comparing saxagliptin plus metformin with sitagliptin plus metformin. The registrational trials assessed the safety and efficacy of Onglyza and involved 4,148 patients with type two diabetes.
The launch of Onglyza is expected to begin in the fourth quarter of 2009.
